FDA Approves SINGULAIR For Seasonal Allergic Rhinitis; A New Class of Therapy for the Treatment of Seasonal Allergic Rhinitis -Also Known as Hay Fever-

Business Wire, Jan 2, 2003

The efficacy of SINGULAIR tablets for the treatment of seasonal allergic rhinitis was investigated in 5 similarly designed, randomized, double-blind, parallel-group, placebo- and active-controlled (loratadine) trials conducted in North America. The 5 trials enrolled a total of 5029 patients, of whom 1799 were treated with SINGULAIR tablets. Patients were 15 to 82 years of age with a history of seasonal allergic rhinitis, a positive skin test to at least one relevant seasonal allergen, and active symptoms of seasonal allergic rhinitis at study entry.

The period of randomized treatment was 2 weeks in 4 trials and 4 weeks in one trial. The primary outcome variable was mean change from baseline in daytime nasal symptoms score (the average of individual scores of nasal congestion, rhinorrhea, nasal itching, sneezing) as assessed by patients on a 0-3 categorical scale.

Four of the five trials showed a significant reduction in daytime nasal symptoms scores with SINGULAIR 10 mg tablets compared with placebo. The efficacy results of one trial are shown below; the remaining three trials that demonstrated efficacy showed similar results. The mean changes from baseline in daytime nasal symptoms score in the treatment groups that received SINGULAIR tablets, loratadine and placebo are shown in Table 3.

                                TABLE 3
     Effects of SINGULAIR on Daytime Nasal Symptoms Score(a) in a
                 Placebo- and Active-controlled Trial
              in Patients with Seasonal Allergic Rhinitis

-----------------   ----------    -------------  ---------------------
Treatment           Baseline      Mean Change    Difference Between
Group (N)           Mean Score    from Baseline  Treatment and Placebo
                                                 (95% CI)
                                                 Least-Squares Mean
-----------------   ----------    -------------  ---------------------
-----------------   ----------    -------------  ---------------------
SINGULAIR 10 mg       2.09           -0.39      -0.13(c)(-0.21, -0.06)
   (344)
-----------------   ----------    -------------  ---------------------
-----------------   ----------    -------------  ---------------------
  Placebo             2.10           -0.26                N.A.
   (351)
-----------------   ----------    -------------  ---------------------
-----------------   ----------    -------------  ---------------------
 Active Control(b)    2.06           -0.46     -0.24(c) (-0.31, -0.17)
(Loratadine 10 mg)
     (599)
-----------------   ----------    -------------  ---------------------

    (a) Average of individual scores of nasal congestion, rhinorrhea,
        nasal itching, sneezing) as assessed by patients on a 0-3
        categorical scale.
    (b) The study was not designed for statistical comparison between
        SINGULAIR and the active control (loratadine).
    (c) Statistically different from placebo (p (less than or equal
        to) .001).

INDICATIONS AND USAGE

SINGULAIR is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.